Novelties in gout

Chronic asymptomatic hyperuratemia (HUA), gout paroxysm in patients with chronic hyperuratemia (HU) and normouricemic attacks of gouty arthritis are well known, but poorly understood. A review of the current literature with attempt of its explanation is presented. The natural course of gout is associated with joint structure changes that may be evaluated by different imaging techniques; comparative advantages and shortcomings of each technique are presented. For almost over 50 years the market has not offered new drugs for the control of HU and gout, while management of such patients was a rather neglected field. Over the last five years an unpredictable number of prospective clinical studies have been conducted involving the investigation of the efficacy and safety of new drugs to control HU (febuxostat, pegloticase). The return of pharmaceutical industry into the world of gout has considerably changed the picture. New recommendations have been presented on appropriate colchicine dose regime for acute gouty flares. Emerging therapies, including pegloticase, uricosuric agent RDEA596 and the interleukin -1 inhibitors have shown promises in early and late phase clinical trials. Each of them deserves to be considered for implementation and feasibility in clinical practice as well as outcome measures for clinical trials. Another purpose of this review was to summarize new knowledge on approved drugs to treat hyperuricemia, or the clinical manifestations of gout. Results of several clinical trials provide new data on the efficacy and safety of the approved urate lowering drugs (allopurinol and febuxostat). Lifestyle and dietary recommendations for gout patients should take into consideration overall health benefits and risks, since gout is often associated with metabolic syndrome and an increased future risk of cardiovascular disease and mortality. This review also summarizes the recent data about lifestyle factors that influence serum uric acid levels and the gout risk, and attempts to provide holistic recommendations, considering both their impact on gout as well as on other health implications.

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VP196 Impact Of Trial Registry Search Features On Searches In CT.gov/ICTRP

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317004238 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 240-241

Author(s):

Elke Hausner ◽

Marco Knelangen ◽

Siw Waffenschmidt

Keyword(s):

Clinical Trials ◽

New Drugs ◽

Health Conditions ◽

Bibliographic Databases ◽

Trial Registry ◽

Search Queries ◽

Search Terms ◽

Advanced Search ◽

Approved Drugs ◽

Clinical Trials Registry

INTRODUCTION:In contrast to bibliographic databases, trial registries do not offer the option of formulating complex search queries, thus making targeted searches more difficult. However, ClinicalTrials.gov (CT.gov) and the International Clinical Trials Registry Platform (ICTRP) offer different search features that may help compensate this limitation. Our aim was to determine the importance of search features (for example, searches using synonyms or, additionally in CT.gov, automatic inclusion of further search fields) for trial registry searches.METHODS:We conducted a project called “Trial registry searches for studies of newly approved drugs” (1). One analysis investigated the question as to whether searches for different health conditions and interventions (new drugs) directly identified registry entries with the search terms entered or whether certain search features were responsible for this. We searched CT.gov and ICTRP for different conditions and interventions using the advanced search interface. For each search, we documented the synonyms listed in the two registries. We imported the registry entries into EndNote and evaluated whether the search terms used were available in the corresponding search fields (condition; intervention).RESULTS:For CT.gov, 96 registry entries on 18 interventions and 190 entries on 12 conditions were analysed. Of these, twenty-three (24 percent) entries for interventions and thirty-eight (20 percent) for conditions were identified by search features, not by search terms. For ICTRP, 32 entries on 10 interventions and 100 entries on 9 conditions were analysed. Of these, five (16 percent) entries for interventions and eight (8 percent) for conditions were identified by search features.CONCLUSIONS:Trial registry search features have an important impact on the sensitivity of searches. Many studies are not identified by the search terms entered, but by searches using synonyms and, additionally in CT.gov, by automatic inclusion of further search fields. Moreover, search features in CT.gov are more effective than in ICTRP – even though the same search terms are used, they consistently yield higher sensitivities.

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Inclusion of Older People Reflective of Real‐World Clinical Practice in Cardiovascular Drug Trials

Journal of the American Heart Association ◽

10.1161/jaha.120.016936 ◽

2020 ◽

Vol 9 (21) ◽

Author(s):

Gillian E. Caughey ◽

Maria C. Inacio ◽

J. Simon Bell ◽

Agnes I. Vitry ◽

Sepehr Shakib

Keyword(s):

Heart Failure ◽

Cardiovascular Disease ◽

Clinical Trials ◽

Venous Thromboembolism ◽

Older People ◽

Real World ◽

Product Information ◽

Drug Product ◽

New Drugs ◽

Efficacy And Safety

Background Underrepresentation of older people in clinical trials remains. This study aimed to examine the inclusion of older people and associated safety and efficacy reports from clinical trials of new molecular entities for cardiovascular disease indications since commencement of the US Food and Drug Administration Drug Trial Snapshot (DTS) Program. The DTS provides concise information on participants included in clinical trials supporting US Food and Drug Administration approval of new drugs. Methods and Results A cross‐sectional analysis between January 1, 2015 and April 30, 2019 of DTS data including approval date, indication, number of trials and participants, age distribution, efficacy, and safety statements was conducted. Participation‐to‐prevalence ratio (PPR) was used to describe representation of older participants in trials relative to disease population. Efficacy and safety statements regarding age were compared with drug prescribing information. A total of 72 079 participants from 10 DTS reports were identified and 39 625 (55.0%) were aged ≥65 years old. Overall, 63.6% of cardiovascular disease DTS reports were representative of people aged ≥65 years old for specific cardiovascular disease conditions. Underrepresentation was observed in 4 DTS: 2 for heart failure (PPR 0.48 and 0.62), 1 for pulmonary arterial hypertension (PPR 0.72), and 1 for venous thromboembolism (PPR 0.38). Participants in clinical trials for new drugs for the treatment of atrial fibrillation (PPR 0.99 and 1.21) and hypercholesterolemia (PPR 0.84 and 0.97) were reflective of the older population for these diseases. An increased risk of adverse events in older participants was reported in 40% DTS safety statements but no differences were reported in the drug product information. Conclusions Despite the fact that >60% of cardiovascular disease trial participants for new molecular entities included in the DTS program were representative of the older population in real‐world clinical practice, concerns remain for conditions including heart failure or venous thromboembolism. Drug product information safety statements regarding age differences in adverse events were not reflective of trial findings. An increased directive is needed to facilitate the generation of real‐world evidence and appropriate reporting within drug product information for these potentially at‐risk patient populations.

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A narrative review of newly approved drugs for COVID-19

10.31219/osf.io/7f3qs ◽

2020 ◽

Author(s):

Rajmohan Seetharaman ◽

Jaisen Lokhande

Keyword(s):

Technical Assistance ◽

Scientific Information ◽

Mechanisms Of Action ◽

New Drugs ◽

Efficacy And Safety ◽

Regulatory Authorities ◽

Viral Structure ◽

The World ◽

Approved Drugs ◽

Regulatory Flexibility

COVID-19 disease is swiftly spreading over the globe. There were no specific approved drugs or therapies at the start of the pandemic. Hence, the management of these patients involves optimized supportive care. Researchers worldwide are analyzing the viral structure viruses pathophysiology to develop new drugs and repurpose the currently approved drugs. Regulatory authorities worldwide, such as the USFDA, EMA, CDSCO, etc. are working closely with these scientists. They are expediting their efforts by providing advice, technical assistance, regulatory flexibility, and leveraging on scientific information from the trials conducted across various parts of the globe. These efforts have led to emergency use authorizations and restricted emergency use approvals of a few drugs, namely remdesivir, favipiravir, and 2% propofol emulsion for use in COVID-19 patients. The USFDA has revoked the approval of chloroquine and hydroxychloroquine. Many more new drugs are in the pipeline for their antiviral or immunomodulatory or other supportive mechanisms of action. These drugs are under the radar of regulatory authorities who are monitoring their efficacy and safety firmly as the world hopes to find a solution to combat this pandemic.

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Benzodiazepines, Amphetamines, Testosterone and Sildenafil as New Candidates Drugs for Sexual Interest, Desire and/or Arousal Disorder

Current Psychopharmacologye ◽

10.2174/2211556010666210301144022 ◽

2021 ◽

Vol 10 ◽

Author(s):

Richard Joseph Wix ◽

Ezequiel Uribe

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Side Effects ◽

Sexual Interest ◽

New Drugs ◽

Hypoactive Sexual Desire Disorder ◽

Arousal Disorder ◽

Approved Drugs ◽

Fda Approved Drugs ◽

Desire Disorder

Background: The FDA approved drugs for female sexual interest, desidere and/or arousal disorder (FSIAD), and hypoactive sexual desire disorder (HSDD), however this have low tolerability for patients because its multiple side effects and does not show real therapeutic efficacy. Hypoactive Sexaul Desire affects from 750.000.000 to 1.400.000.000 people worldwide. Methods: In this paper we analyze therapeutic candidate in clinical practice as well as the methodologies clinical trials of possible therapeutic targets of different systems related to the dysfunction. Results: Therefore New Drugs (Benzodiazepines, Amphetamines, Testosterone, Sildenafil or New Compound) Clinical Trials to treat this disorder are necessary.

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DOES HEPARIN HAVE AN ESSENTIAL ROLE IN THE TREATMENT OF THE COVID-19 PANDEMIC? A REVIEW

Global Journal of Public Health Medicine ◽

10.37557/gjphm.v3i1.84 ◽

2021 ◽

Vol 3 (1) ◽

pp. 374-385

Keyword(s):

Infectious Disease ◽

Clinical Trials ◽

Severe Acute Respiratory Syndrome ◽

Prothrombin Time ◽

Inflammatory Mediators ◽

Observational Studies ◽

Essential Role ◽

Clinical Manifestations ◽

Efficacy And Safety ◽

Plasma Markers

Coronavirus 2019 (COVID-19), is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It was first reported in December 2019. The plasma markers of coagulation, like D-dimers and elevated prothrombin time (PT) are higher in patients with COVID-19. The administration of anticoagulant is beneficial in those patients. Heparins have many therapeutic functions that are important for the controlling of COVID-19-associated clinical manifestations like, neutralization of inflammatory mediators and neutralization of extracellular cytotoxic histones. Many observational studies in different countries have been done and large number of clinical trials have been designed and registered to evaluate efficacy and safety of heparin for patients with COVID-19. The aim of this narrative review is to summarize all available data from previously published studies concerning the use of heparin in treatment of the COVID-19 pandemic.

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New approved drugs for psoriatic arthritis

Reumatismo ◽

10.4081/reumatismo.2016.873 ◽

2016 ◽

Vol 68 (2) ◽

pp. 57 ◽

Cited By ~ 4

Author(s):

F.M. Perrotta ◽

E. Lubrano

Keyword(s):

Clinical Trials ◽

Psoriatic Arthritis ◽

Structural Damage ◽

Randomized Clinical Trials ◽

Poor Quality ◽

Chronic Inflammatory Disease ◽

New Drugs ◽

Approved Drugs ◽

Symptoms And Signs

Psoriatic arthritis (PsA) is a chronic inflammatory disease that possibly leads to structural damage and to a reduction of joint function and poor quality of life. Treatment of PsA has changed since its introduction of anti- TNF drugs, which have shown to reduce the symptoms and signs of the disease and slow the radiographic progression. However, recently, the discovery of new pathogenic mechanisms have made possible the development of new molecules that target pro-inflammatory cytokines involved in skin, joint and entheseal inflammation. New drugs like ustekinumab, secukinumab and apremilast inhibit interleukin axis and intracellular pathways and showed their efficacy and safety in randomized clinical trials. These drugs have been recently approved for the treatment of PsA and included in the new EULAR and GRAPPA treatment recommendations. The aim of this paper is to briefly review the clinical trials that led to their approval for PsA.

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